OUR WHITEBOARD WEDNESDAY ON DECEMBER 16TH IS CRUCIAL TO YOUR ZANTAC MDL CASES.
To date, there are more than 50,000 cases filed into the Zantac/Ranitidine MDL.
Are you aware that the DEFENDANTS will be actively attempting to have your Plaintiff’s cases thrown out by claiming that they have stopped marketing that particular Ranitidine product based on their “end marketing” dates. YOU WILL UNDERSTAND HOW TO COUNTER THIS TACTIC AND SAVE YOUR CASES after participating in Whiteboard Wednesday.
MTN has unraveled a far-reaching conspiracy (and identified the major conspirators) that produced, packaged, distributed and sold approximately 1,000 various Ranitidine products by employing a scheme involving obtaining multiple National Drug Code’s, for finished products with branding and labeling that was never approved by the FDA and for that matter, could not be approved by the FDA.
Although the appearance of an NDC code on a finished drug product might lead a consumer to believe that product, as labeled, was approved by the FDA, nothing could be further from the truth.
Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR §207.37 (a)(2))
This is how the scheme worked: A single drug maker would obtain ANDA approval, including the labeling for a single finished product, in various sizes or counts appropriate for sale to a retail class of consumers. That ANDA holder would then fill large containers, up to drums of 60,000 pills, which would be shipped to a repacking company. The repacking company would remove the pills from the bulk containers and fill containers with retail store branding and labeling not approved by the FDA.
The narrow allowance for repackaging approved drug products is limited to the ANDA or NDA holder allows repacking entity to produce containers in counts or sizes not produced by the application holder, for sale to hospitals and other institutions. The only change permitted to the FDA approved labeling for the specific product is the addition of the repacking entities name and address, under the manufacturers name and address on the FDA approved labeling. Under no circumstance should a repackaged product end up on a retail shelf, behind the drug counter or as an OTC drug in the retail section of any store.
The creation of counterfeit finished drug products as described above, is a Federal crime in violation of 21 U.S. Code § 331 (k), § 331 (a) and § 331 (b) and is punishable under of 21 U.S. Code § 333 by up to 10 years in prison and a $10,000.00 fine for each individual unit of product entered into the stream of commerce.
MTN has reviewed, documented, and collected the NIH and FDA database information as well as other evidence of the roles the various conspirators played in the scheme. IT’S A BOMBSHELL!
ONCE YOU UNDERSTAND THE LAWS/REGULATIONS SURROUNDING THIS, YOU WILL BE ARMED TO IDENTIFY A COUNTERFEIT RANITIDINE PRODUCT IN VIOLATION OF 21 U.S. Code § 331. THRU REVIEW OF THE SPL (STRUCTED PRODUCT LABELING) INFORMATION AND OTHER EVIDENCE IN OUR POSESSION. WITH THIS INFORMATION AND EVIDENCE IN HAND, YOU WILL BE ABLE TO DISCREDIT ANY AVERMENTS OF THESE DEFENDANTS CLAIMING THAT THEY HAD CEASED MARKETING A GIVEN PRODUCT AT THE TIME YOUR CLIENT CLAIMS TO HAVE PURCHASED THAT PRODUCT.
THE DEFENDANTS THAT PARTICIPATED IN THE SCHEME COMPLETELY IGNORED THE REQUIREMENTS OF THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA). ANY CLAIM OR AVERMENT MADE BY THESE DEFENDANTS THAT CONTRADICTS A PLAINTIFFS CLAIM REGARDING WHEN THEY PURCHASED A GIVEN PRODUCT, CAN BE REFUTED WITH OFFICAL RECORDS AND OTHER EVIDENCE IN OUR POSESSION. ADDITIONALLY, THE VERACITY OF ANY AVERMENT MADE BY THESE DEFENDANTS CAN BE CHALLANGED.
To provide clarity on WHAT THE DEFENDANTS ARE HIDING, you will receive John Ray’s White Paper prior to 12/16 for your review AND all of this ground breaking information will all be discussed in further detail on the Zantac/Ranitidine Whiteboard Wednesday.